Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.

Truvada once daily with continuation of the current NNRTI or PI at randomization

Drug: Truvada

Truvada + NNRTI or PI.

Active Comparator: Maintain Baseline Regimen

Maintain baseline regimen

Drug: Current HAART regimen

Maintain baseline regimen

Experimental: Delayed Truvada

Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)

Drug: Truvada

Truvada + NNRTI or PI.

Experimental: All Truvada

Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)

Drug: Truvada

Truvada + NNRTI or PI.

Detailed Description:

This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

A. Truvada (substitution of their current NRTIs by Truvada [FTC/TDF] with continuation of their current NNRTI or PI at the same dose)

Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).

Patients were assessed for efficacy and safety during both phases of the study.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00323492